AS/NZS 2869:1995

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Australian/New Zealand Standard

Tampons—Menstrual
 AS/NZS 2869:1995

This Joint Australian/New Zealand Standard was prepared by Joint Technical

Committee CS/65, Tampons. It was approved on behalf of the Council of Standards
Australia on 30 November 1994 and on behalf of the Council of Standards
New Zealand on 6 December 1994. It was published on 5 March 1995.

The following interests are represented on Committee CS/65:

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Australian Federation of Consumer Organization

Australian Society for Microbiology
Department of Health and Community Services, Vic.
Department of Health New Zealand
Department of Human Services and Health (Commonwealth)
Federal Bureau of Consumer Affairs (Commonwealth)
Grocery Manufacturers of Australia
National Health and Medical Research Council, Australia
Queensland Health
Retailers Council of Australia
Royal Australian College of Obstetricians & Gynaecologists

Review of Standards. To keep abreast of progress in industry, Joint Australian/

New Zealand Standards are subject to periodic review and are kept up to date by the
issue of amendments or new editions as necessary. It is important therefore that
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amendments thereto.
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taken.

This Standard was issued in draft form for comment as DR 93065.

 AS/NZS 2869:1995
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Australian/New Zealand Standard

Tampons—Menstrual

First publi shed as AS 2869—1986

Jointl y revised and designated as Joint Standard
AS/NZS 2869:1995

Incorporating:
Amdt 1—1995

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA
1 The Crescent,
Homebush NSW 2140 Australia

STANDARDS NEW ZEALAND

Level 10, Standards House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7262 9535 3
 AS / NZS 2869:1995 2

PREFACE

This Standard was prepared by the Standards Australia/Standards New Zealand Committee
CS/65 on Tampons at the request of the Department of Human Services and Health
(Commonwealth) Therapeutic Goods Administration as a Joint Standard to supersede
AS 2869 —1986.
The initial request for a Standard for tampons followed the confirmation, in 1981, of
several cases of Toxic Shock Syndrome (TSS) in Australia which were associated with the
use of tampons by menstruating women.
Although the incidence of TSS in Australia and New Zealand is low, and investigations
have shown that unopened tampons have not been contaminated by Staphylococcus aureus
(the microorganism associated with TSS), the Committee believed the development of a
Standard was highly desirable so that this position did not deteriorate. In addition, the
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Committee agreed that there were other aspects which also related to the health and
comfort of users that should be dealt with in such a Standard.
The first edition therefore concerned itself with these aspects by specifying materials,
performance tests for absorptive capacity, the strength of the withdrawal cord, a microbial
count to detect possible contamination during manufacture, instructions for hygienic use,
and information about TSS and its warning symptoms, which was based on the
recommendations of the National Health and Medical Research Council.
This edition of the Standard was undertaken to provide legislative interests with a revision
suitable for reference in legislation, with particular regard to the need of objective
labelling. It includes a table of absorbency ranges and descriptors for different tampon
types, giving phrases to be used for product labelling by manufacturers. These phrases are
intended to provide the tampon user with information that will allow her to select
products with equivalent absorbency, irrespective of the brand. No descriptive phrase is
given for tampons with an absorptive capacity of less than 7 g, as these are not widely
available in Australia and New Zealand.
The microbial limit given in this Standard has been the subject of much discussion during
the course of this revision, particularly as the Committee is not aware of any other
country which includes such a requirement in its Standards or regulations. The microbial
limit set in this Standard is intended as a manufacturing specification which is achievable
by a manufacturer who adheres to an appropriate quality management system. Experience
has shown that the microbial counts at the time of use will tend to be lower.
The terms ‘normative’ and ‘informative’ have been used in this Standard to define the
application of the appendix to which they apply. A ‘normative’ appendix is an integral
part of a Standard, whereas an ‘informative’ appendix is only for information and
guidance.

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 3 AS / NZS 2869:1995

CONTENTS
Page

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .. .. .. .. ... ........... 5

2 OBJECTIVE . . . . . . . . . . . . . . . . . . . . . . . ... ... ... .. .. ... ... ....... 5
3 REFERENCED DOCUMENTS . . . . . . . . . . ... ..... ..... ..... ... .. .. . 5
4 DEFINITIONS . . . . . . . . . . . . . . . . . . . . . ...... ... .. .. .. .. ... ...... 5
5 MATERIALS . . . . . . . . . . . . . . . . . . . . . . ..... ... .. .. .. .. ... ....... 6
6 DESIGN REQUIREMENTS . . . . . . . . . . . . .. ............. ... .. .. .. .. 7
7 PERFORMANCE REQUIREMENTS . . . . . .. .. .. ... ............. ... . 7
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8 MICROBIAL CONTENT . . . . . . . . . . . . . . ............. ... .. .. .. .. .. 7

9 PACKAGING . . . . . . . . . . . . . . . . . . . . . . .... ... ... .. .. ... ... ...... 7
10 MARKING . . . . . . . . . . . . . . . . . . . . . . . . ... ... .. .. .. .. ... ......... 7
11 INFORMATION LEAFLET . . . . . . . . . . . . .. ............. ... .. .. .. .. . 8

APPENDICES
A Removed as per Amdt No. 1
B Removed as per Amdt No. 1
C METHOD FOR MEASURING ABSORPTIVE CAPACITY . . . . . . . . . . . . . . 12
D METHOD FOR TESTING THE STRENGTH OF THE WITHDRAWAL
CORD AND ITS ATTACHMENT TO THE TAMPON . . . . . . . . . . . . . . . . . 16
E METHOD FOR DETERMINING THE WATER REPELLENCY
OF THE WITHDRAWAL CORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
F METHOD FOR DETERMINING TOTAL AEROBIC MICROBIAL COUNT . . 22
G EXAMPLE OF INFORMATION ON TSS FOR INCLUSION
IN INFORMATION LEAFLET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
H EXAMPLE OF SAMPLE SIZE CALCULATION . . . . . . . . . . . . . . . . . . . . . 27
 AS / NZS 2869:1995 4

FOREWORD

The name Toxic Shock Syndrome (TSS) was first applied to a condition characterized by
toxaemia associated with Staphylococcus aureus. In 1980, cases resembling TSS were
reported in the United States of America; almost all were in menstruating women and an
association with tampon use was found. However, the exact connection between S. aureus,
menstruation and tampons is not fully understood. TSS is a toxaemia caused by a toxin,
TSST-1, produced by some strains of S. aureus.
Cases of TSS have also been confirmed in non-menstruating women, in men and in
children where it has been associated with local infections caused by S. aureus. There is
no record of anyone contracting TSS from someone who has already had the disease.
Extensive investigations in Australia and New Zealand have revealed no evidence of
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contamination of unopened tampons by S. aureus, but evidence suggests that tampon use
in association with staphylococcal infection is important in the disease.
Intensive investigation was carried out by the US Centers for Disease Control (CDC),
Atlanta, Georgia. Studies indicated that the organism S. aureus was found in the vagina of
98% of women suffering from TSS who had cultures taken before receiving antibiotics.
S. aureus is found in the vagina of about 10% of healthy women.
Although it is acknowledged that the vagina can be colonized with staphylococci, every
precaution should be taken during the manufacture of the tampon and in the design of the
package to ensure that contamination of the tampon does not occur.
It is also important that women using tampons be aware of the need for special care with
personal hygiene during menstruation and with the way in which they handle the tampon,
and also that they recognize the symptoms of TSS, should it occur.
 5 AS / NZS 2869:1995

STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND

Australian/New Zealand Standard

Tampons—Menstrual

1 SCOPE This Standard specifies requirements for menstrual tampons, including the
specific absorptive capacity, microbial content, withdrawal cord pull strength and water
repellency, marking and packaging. Information to be included in an accompanying leaflet
is described.

2 OBJECTIVE The objective of this Standard is to ensure that tampons are

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manufactured to requirements that will minimize known hazards to health associated with
the use of tampons, and are of appropriate quality and performance when supplied to
consumers.

3 REFERENCED DOCUMENTS The following documents are referred to in this

Standard:
AS
1386 Cleanrooms and clean workstations
1766 Food microbiology
1766.2.1 Standard plate count
1766.2.2 Colony count of yeast and moulds
1766.5 Preparation of media, diluents and reagents
2001 Methods of test for textiles
2001.3.4 Chemical tests—Determination of solvent-soluble matter
2193 Methods for calibration and grading of force-measuring systems of testing
machines
2243 Safety in laboratories
2243.1 Part 1: General
2243.2 Part 2: Chemical aspects
2243.3 Part 3: Microbiology
2252 Biological safety cabinets
2252.2 Part 2: Laminar flow biological safety cabinets (Class II) for personnel and
product protection
2490 Sampling procedures and charts for inspection by variables for percent
defective
2508 Safe storage and handling information cards for hazardous materials
2508.3.017 Ethanol/methylated spirits
2766 Petri dishes—Plastics—For single use

4 DEFINITIONS For the purpose of this Standard, the following definitions apply:
4.1 Aseptic technique—the exercise of special procedures for maintaining sterility of
equipment, media and suchlike, or the purity of cultures by eliminating adventitious
contamination and for protecting the operator and environment.

COPYRIGHT
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